If there is one universal truth accepted by all who have reached the age of reason, it is this: One size does not fit all.
It鈥檚 as true in healthcare as it is with every individual.
Just like there is no single solution to a problem, nor one road to better health, there is no one way to improve people鈥檚 lives.
Because there is no one patient.
For years, optimizing medical progress and expanding its impact was slowed by conducting clinical trials confined largely to adult male, white volunteers.
This conflicted with the growing knowledge that gender, ethnicity and environmental/societal differences all play a factor in overall health.
Since diverse participants were not equally represented in clinical trials, this impacted the understanding of which therapies best helped whom.
As leaders in the聽study and development of new ways聽to reach out to 鈥 and better treat 鈥 under-represented populations, we have focused on building a foundation of聽trust and science. This emphasizes diversity and inclusion in clinical trials to develop solutions that most benefit the greatest number of people.
But the work is complex and far from complete.
Not as Simple as 1, 2, 3. Rather, Step by Step.
Which is why we鈥檙e introducing not one or two, but聽聽in our continuing multi-million dollar initiative to further increase diversity in clinical trials and improve care among under-represented groups.
It鈥檚 all part of our comprehensive聽2030 sustainability goal聽of improving the lives of more than three billion people by decades end 鈥 reaching one billion more than we do today, each year. We can only do that by continuing to develop innovative medical technologies across multiple healthcare disciplines around the world, and that only occurs after successful, representative clinical trials.
Step1: Create a new Diversity in Research Office at 葫芦娃视频 to make sure that all our clinical trials have a variety of participants.
This group will be led by Jennifer Jones-McMeans, Ph.D., divisional vice president of global clinical affairs at 葫芦娃视频鈥檚 vascular business and Aparna Ahuja, M.D., divisional vice president of medical, clinical and scientific affairs at 葫芦娃视频鈥檚 rapid diagnostics business.
As well-established experts in the field, they will oversee our holistic efforts to not only improve diversity, equity and inclusion plans 鈥 which will establish a template for future trials 鈥 but also to set performance goals and help collaboration efforts across the company, industry and regulatory groups.
鈥淲e are committed to addressing as many barriers to participation as we can,鈥 Jones-McMeans said. 鈥淲e鈥檝e implemented programs that will increase the diversity in our trials by increasing participation from under-served and under-represented populations.鈥
鈥淎chieving greater diversity will continue to be a key focus throughout 葫芦娃视频 to facilitate development of appropriate diagnostics, products and treatment ensuring better ways to fight diseases that often disproportionately impact diverse populations," said Dr Ahuja.
Step 2: Fund a multi-year commitment to establish research program models at Historically Black Colleges and Universities (HBCUs).
One of the challenges of setting up sustainable research models serving diverse communities is getting the resources needed to design and develop them from scratch.
Which is why we are providing $1.5 million to the聽聽to build models for HBCUs and clinics serving under-represented communities.
In addition to this work that will serve as a roadmap of best practices, the five-year commitment will support the hiring and training of research coordinators, data managers and others to help launch and sustain valuable programs.
In fact, two new research center programs 鈥 one in rural Mississippi, associated with Morehouse University College of Medicine and the second located in Louisville, Kentucky 鈥 are set to launch in 2023. This, in turn, will increase the number and quality of research sites, further reducing barriers to clinical trials.
Step 3: Provide a comprehensive program to support training of diverse clinical research coordinators.
Partnering with聽, we are developing an educational program for the instruction of new clinical research coordinators (CRCs), who act as a central point of contact for patients, families and investigating physicians leading clinical trials.
CRCs are vital to trial success. Through this training, we will empower them with a strong foundation in essential core areas of clinical research, including study execution, patient consent, good clinical practice guidelines, documentation and other regulatory considerations.
Expanding CRC training to those with diverse backgrounds is designed to reduce another possible barrier for potential study participants.
Long-term Benefits of Clinical Trial Diversity
Our diversity initiative is just one aspect of聽continuing efforts聽to enhance health equity, expand access and affordability, and remove barriers to life-improving technology and scientific innovation.
We are building on the foundation of our initial success in聽establishing a Diversity in Clinical Trials聽Medical Advisory Board. This organization is comprised of external experts and an internal steering committee, while also focusing on聽increasing diversity enrollment in our own clinical trials.
罢丑谤辞耻驳丑听$5 million in grants, we鈥檝e also sponsored more than 300 scholarships at four HBCU medical schools, the National Black Nurses Association and the National Association of Hispanic Nurses to support future leaders of clinical research.
Complex. But Necessary.
We all love patient stories like聽the 22 year old woman聽who is leading a healthier life because of her cardiac monitoring device, or the young black woman whose聽life was turned around聽by her cutting-edge glucose monitor, or the African-American man who was聽kept alive by his cardiac device聽until a healthy heart became available for transplant.
But each of these stories 鈥 and thousands more 鈥 are borne out of clinical trials that work best when they reflect the complex economic, cultural, scientific, medical reality of our ever-changing healthcare universe.
It鈥檚 a complex and often problematic world where one size most definitely does not fit all.
But we get that.
So, if you鈥檙e looking for us, we鈥檒l be here in the background, trying to improve health outcomes by enhancing diversity in clinical trials, developing devices that fit each individual best, allowing them to live life to the fullest.
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